FDA.reportPublic FDA data

BIOS Professional

Primary DI
00057475696009
Brand
BIOS Professional
Company
Thermor Ltd
Model
FS600
Device description
Disposable Face Masks, Box of 50
Published
2023-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475696006PackageGS140In Commercial Distribution
00057475696009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747569600610057475696006
00057475696009000574756960090574756960090057475696009

GMDN Terms#

Term, Definition table
TermDefinition
Public face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246883458
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475220495BIOS Diagnostics220DI2023-09-20
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975089780010DISPOSABLE FACE MASKHubei Qifu Protective Products Co.,LtdQKR2025-12-23
40841767107711Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-09-07
00841767107713Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-09-07
40841767107728Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-30
00841767107720Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-30
10841767106034Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106004Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106011Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106028Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106226Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106037Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106006Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106013Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106020Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106228Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
04007418891141Medical Face MaskHans Hepp GmbH & Co. KGQKR2023-07-28
04007418891158Medical Face MaskHans Hepp GmbH & Co. KGQKR2023-07-28
40841767107650Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-03-28
00841767107652Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-03-28
06974424843502LEBOOLeboo Healthcare Products LimitedQKR2023-03-21
00810084932094WeCareJeg & Sons Inc.QKR2022-12-16
00810084939314WeCareJeg & Sons Inc.QKR2022-12-16
06973509180006TongdaXiantao Tongda Non-Woven Products Co., Ltd.QKR2022-12-02
088097834906243PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834906314PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834905253PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834905324PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
07506561200130INDALJIMTMIndaljim, S.A. de C.V.QKR2022-01-28
00816703025864MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13
00816703025871MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13